NCT07114120RecruitingPhase 4
Clinical Study on the Treatment of Stable Bronchiectasis With Bailing Capsules Combined With Guben Kechuan Granules
Source: ClinicalTrials.gov · Last updated 11 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to learn if Bailing Capsules in combination Guben Kechuan Granules works to treat stable bronchiectasis in adults.It will also learn about the safety of Bailing Capsules in combination Guben Kechuan Granules The main questions it aims to answer are: Does Bailing Capsules in combination Guben Kechuan Granules lower the number of acute exacerbation in patients with stable bronchiectasis? The safety of the combination of Bailing Capsules and Guben Kechuan Granules ? Researchers will compare the combination of Bailing Capsules and Guben Kechuan Granules to standard Western medical treatment to see if them works to treat stable bronchiectasis. Participants will: Take Bailing Capsules orally (four capsules each time, three times a day) and Guben Kechuan Granules ( three times a day, 1 bag each time )on the basis of standard Western medical treatment or only standard Western medical treatment for 24 weeks Visit the clinic for checkups and tests on 4, 12, 24, 48 weeks Keep a diary of their symptoms
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 214 (estimated)
- First submitted
- 19 Jun 2025
- Start date
- 14 Jul 2025
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- COPD
- NCT number
- NCT07114120
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 214
- From 14 Jul 2025 to the primary completion date, 30 Oct 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous respiratory diseases other than bronchiectasis (such as bronchial asthma, lung cancer, active pulmonary tuberculosis, interstitial lung disease, pulmonary thromboembolism and severe pneumonia, etc.);
- Inability to swallow the research drug;
- Participate in other clinical trials, use other research drugs or research devices within 30 days before randomization;
- Other traditional Chinese medicine treatments were used within 7 days before the use of the study drug and during the study period.
Other illness
- Bronchiectasis caused by cystic fibrosis, allergic bronchopulmonary aspergillosis, etc;
- Combined with serious diseases of the heart, liver, kidneys, digestive system, blood system, etc., evaluated by the researcher, including but not limited to acute severe hepatitis, liver failure, liver cirrhosis, acute renal failure, acute myocardial infarction, heart failure, gastric perforation, gastrointestinal bleeding, gastric cancer, intestinal cancer, acute leukemia, acute aplastic anemia, etc., subject to the judgment of the researcher;
- Known allergy to the test drug;
- In the past year, there has been a history of alcohol abuse, drug abuse or drug abuse;
Lab values
- Abnormal liver function was found in the patient screening examination, with the following criteria: total bilirubin \> 1.5×ULN; ALT \> 3×ULN; AST \> 3×ULN;
Age
- Women or men of childbearing age refused to use contraceptive measures during the study period;
Other
- Dry bronchiectasis mainly characterized by hemoptysis;
- Pregnant or lactating women;
- Any other factors that may not be suitable for participation in clinical research as determined by the researcher;
Who the study is looking for
- 18-80 years old, gender not limited;
- It conforms to the Western medical diagnosis of bronchiectasis;
- There has been no acute exacerbation or respiratory tract infection in the past 4 weeks. (Acute exacerbation is defined as the deterioration of three or more of the following six conditions: cough, changes in sputum volume, purulent sputum, breathing difficulties or exercise tolerance, fatigue or discomfort, and hemoptysis, lasting for more than 48 hours, and considered by the clinician to require treatment);
- There have been at least two documented acute exacerbations in the past year, prescribed by doctors and diagnosed as signs and symptoms of respiratory tract infections;
- Pulmonary function tests can be conducted, and there is evidence of airflow limitation when screening vital capacity (FEV1/FVC ratio \<70%, and clinically stable at the time of entering the study);
- Voluntarily participate in this clinical trial and sign the informed consent form.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Huzhou Central Hospital Coordinator of this site? Confirm its status | Huzhou | China | Not yet recruiting |
| Jinhua Central Hospital Coordinator of this site? Confirm its status | Jinhua | China | Not yet recruiting |
| Yueqing People's Hospital Coordinator of this site? Confirm its status | Yueqing | China | Not yet recruiting |
| Zhoushan hospital Coordinator of this site? Confirm its status | Zhoushan | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.